510(k) Report

Devices descending from K080235

7 later devices reach Safety Infusion Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121908Safety Infusion SetGreiner Bio-One North America, Inc.20126—
+2K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetGreiner Bio-One Na, Inc.20182—
+2K170276Safety Blood Collection Device for Single UseGemtier Medical (Shanghai), Inc.20172—
+3K214075Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection /…Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20221—
+3K211293Safety Winged Blood Collection SetsPromisemed Hangzhou Meditech Co., Ltd.20211—
+4K243806Safety Winged Blood Collection SetsPromisemed Hangzhou Meditech Co., Ltd.20250—
+4K232881Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection…Jiangsu Kangbao Medical Equipment Co., Ltd.20230—